Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Performs chemical testing to Raw Material, Initials, In-Process Analysis, Water Analysis and Final Chemical Analysis to finished goods; assuring that the company comply with all internal and external regulations.
Essential Duties and Responsibilities:
Responsible to achieving accurate laboratory testing results lies with the analyst who is performing the test.
Should be aware of potential problems that could occur during the testing process and should watch for problems that could create inaccurate results.
Analyzes finished product samples versus specified parameters, using specifications and chemical procedures (eg. Drug solutions).
Analyzes purchase raw materials against established procedures assuring compliance with all regulations and specifications.
Review and/or approval of laboratory documentation.
Must follow the current Good Manufacturing Practices (cGMP’s),current Good Documentation Practices (cGDP’s) and current Good Laboratory Practices (cGLP)
Complies with the established milestones for projects and provides the required support.
Audits chemical test procedures, retests, additional testings and SOP's in the laboratory.
Requests and order all materials required in the laboratory on timely basis to assure an efficient performance (make request of accessories, equipment, reagents, etc.; including the issuance of purchase orders).
Initiates and implement changes or new chemical procedures including data gathering.
Provides routine maintenance, trouble shoots the equipment related to laboratory tests such as: UPLC, HPLC's, GC, IR, UV, etc.
Capable to develops, modifies and analyzes protocols and procedures as required.
Assist the Sr. Chemist to performs special tests and routine chemical tests to raw materials and finished products.
Prepares general material and solutions needed for laboratory tests, as required.
Sanitize the work areas before and after operations.
Keeps the work area in the most clean and order conditions.
Should be able to work within minimum supervision.
Should be able to work with many projects and handle multiple tasks at the same time.
Willing to work extra hours, at any shift when its required, on Holidays and during special periods (eg. shutdowns, internal and external audits, special projects).
Performs statistical data evaluation (such as: Water analysis, etc.), as required.
Run and troubleshoots the laboratory computer systems, as requires
Performs laboratory tests; and prepares and evaluates control charts, using laboratory data.
Team worked oriented and participate in laboratory audits.
Review chemistry documentation.
- list of all responsibilities, duties and skills required of personnel so classified.
COMPANY REGULATORY COMPLIANCE
Observe and promote company security, industrial hygiene, cGMP's, procedures and other security measures already established by the company; should inform any violation.
While performing the duties of this job, the employee is regularly required to stand and walk. The employee frequently is required to use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to sit. The employee must occasionally lift and/or move up 10 to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles, toxic or caustic chemicals, extreme cold, risk of electrical shock, explosives. The employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually moderate.
EQUIPMENT and/or SAFETY EQUIPMENT
The employee is required to use the appropriate Safety Equipment that Baxter requires to comply with all Safety and Security rules (in Regulated Areas), such as: safety glasses, safety shoes, uniform, special safety suit, gloves, etc.
While performing the duties of this job, the employee is required to use the appropriate equipment such as: computer, calculator, telephone, fax machine, copy machine, general and specialized laboratory equipment.
The above statement are intended to describe the general nature an level or work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Qualifications for this role
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, internal and external audits. Fully bilingual (English and Spanish languages).
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Education and Experience
B.S. in Chemist (Master Degree desirable but not required) Puerto Rico Chemist License (required). At least two years of experience in a Pharmaceutical Industry (preferable). Strong knowledge in HPLC, Atomic Absorption, FT-IR, Karl Fisher, UV/VIS, TOC Analyzer, Polarimeter. Strongly oriented to GMP’s, GLP’s, OSHA, US Pharmacopeia, EP, Good troubleshooting resolution techniques. Strong knowledge in LIMS etc..
CERTIFICATES, LICENSES, REGISTRATIONS
cGMP's Training, Chemist license, Confined Spaces Training; and other certificates or licenses that the immediate supervisor refers.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.